Senior Associate, General Information Technology (P)

Insmed Incorporated

22h

About The Position

The IT GxP Systems Engineer serves as a key liaison between IT, Quality Assurance (QA), and system owners to ensure regulated IT systems remain compliant with GxP requirements. This role is responsible for executing impact assessments for system releases, managing IT-related change controls, deviations, and CAPAs, and ensuring all documentation and processes adhere to regulatory standards. As part of the Support Services department, this engineer takes a broad ownership approach — supporting a range of IT systems, independently managing projects end-to-end, and continuously building expertise across new platforms and technologies as business needs evolve. While GxP compliance remains a core focus, the role is designed for someone who thrives in a dynamic environment, picks up new systems quickly, and proactively contributes beyond a defined scope.

Requirements

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field.
• 3+ years of experience in IT systems support within a regulated (GxP/FDA/EU) environment.
• Strong understanding of 21 CFR Part 11, Annex 11, and computer system validation principles.
• Experience managing IT change controls, deviations, CAPAs, and quality documentation.
• Demonstrated ability to independently manage projects and take ownership of systems and processes.
• Ability to learn and support a variety of IT systems across different functional areas.

Nice To Haves

• Familiarity with regulated IT applications commonly used in life sciences or laboratory environments.
• Knowledge of ITIL or service management workflows for change and incident management (e.g., ServiceNow).
• Prior audit support experience (internal or regulatory).
• Experience supporting systems across multiple domains (e.g., identity management, document control, laboratory, financial, or operational systems).

Responsibilities

• Ensure GxP systems remain in a validated and compliant state through lifecycle management.
• Perform release impact assessments for upgrades, patches, and configuration changes.
• Maintain complete and accurate documentation aligned with regulatory and internal SOPs.
• Support periodic user access audits and ensure access complies with role-based controls.
• Initiate and manage IT change controls, ensuring risk assessments and approvals are completed.
• Handle deviations and support investigation, root cause analysis, and remediation activities.
• Draft and implement CAPAs to address compliance gaps or audit findings.
• Take ownership of assigned GxP and non-GxP IT systems, serving as the primary point of contact for issue resolution, enhancements, and stakeholder communication.
• Support the broader IT systems portfolio within the Support Services department as needed, including non-primary systems, to ensure continuity and coverage.
• Independently manage IT projects from initiation through completion, including scoping, coordination, and delivery with minimal supervision.
• Proactively learn and develop proficiency in new systems and technologies as the department's needs expand.
• Coordinate with vendors and internal subject matter experts for system upgrades, issue resolution, and enhancements.
• Partner with QA, CSV, and IT system owners on validation activities and ongoing compliance needs.
• Support internal and external audits by providing system documentation and evidence.
• Maintain traceability across requirements, risk assessments, and test documentation.
• Ensure SOPs, work instructions, and system records are kept current and accurate.
• Support periodic system reviews and revalidation efforts.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees